An Alternative Assessment in Patients with Rheumatoid Arthritis: 6 Minute Step Test

NCT06838884 | Recruiting

• 1 other identifier: 2024/15-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Although joint involvement is predominant, RA is a systemic disease that can affect many organs. RA is a disease that includes changes such as inflammation, joint pain, fatigue, increased risk of coronary and heart disease. In patients with RA, exercises should be planned for decreased muscle strength, endurance, aerobic capacity and affected normal joint movements. Aerobic exercise capacity should be measured for individualized exercise planning in rehabilitation. Bicycle ergometer, one of the aerobic capacity tests, has been used in rehabilitation for a long time. Although it is frequently used in rehabilitation, it has some disadvantages. Therefore, other tests such as the step test can be used to eliminate these disadvantages of the bicycle ergometer and to assess functional capacity. The 6-minute step test (6MST), which requires less time and space, can be used as an alternative to assess exercise capacity. Patients will be evaluated at Firat University Hospital. Patients diagnosed with RA, older than 18 years of age and with a body weight of 100 kg or less (maximum weight supported by the stepper) will be included in the study.

Conditions

Rheumatoid Arthritis (RA; 6 Minutes Stepper Test

Keywords

Rheumatoid arthritis; 6 minutes stepper test; Bicycle ergometer

Outcome Measures

Primary Outcomes (1)

• Modified Borg Scale

  The modified Borg scale is a validated scale for the subjective perception of dyspnea, used to verify the degree of respiratory distress. Exercise intensity is determined by individualized measurement. The 2002 guidelines of the American Thoracic Society recommend the modified Borg scale as an aid. This is a vertical scale measured from 0 to 10. Here 0 represents no symptoms and 10 represents maximum symptoms. In this study the modified Borg scale will be used to rate dyspnea and leg fatigue. The Borg scale will be printed out and this printout will be used for patient enumeration. The patient will be told what the numbers from 0 to 10 on the Borg scale mean. Instructions to the patient: "On the paper in your hand you see the numbers from 0 to 10. 0 means none, 10 means very severe. What the other numbers in between mean is written next to them. Now I want you to describe your breathing difficulty and leg fatigue with a number". After these instructions, the patient will be asked to n

  up to 30 minutes

Study Arms (1)

Evaluated Group

EXPERIMENTAL

In this single-group study, two tests will be performed and compared. A 6-minute stepper test and a bicycle ergometer test will be applied.

Other: 6 minutes step test and bicycle ergometer

Interventions

6 minutes step test and bicycle ergometer OTHER

Evaluation

Evaluated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RA patient
• Over 18 years of age
• kilos or less
• Patients who can walk independently without an assistive device

You may not qualify if:

• History of serious heart and lung disease
• Presence of severe musculoskeletal and joint disorders that may interfere with the conduct of the test
• Arthroplasty or major operations on knee and hip joints
• Uncontrolled hypertension
• Inability to participate in physical tests involving walking and cycling

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University

Merkez, Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Havvagül Doğan

CONTACT

+904242370000; havvvaguldogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: February 18, 2025
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)